To ascertain the potential symptom improvement assessed by Cardiopulmonary Exercise Testing (CPET) in subjects with heart failure with preserved ejection fraction (HFpEF) and nonthrombotic iliofemoral venous lesions and/or iliocaval obstruction defined by MR or CT venography AND CEAP Clinical Category ≥3 prior to venous stenting.
Primary Objective: Evaluate potential improvement in metrics of functional capacity assessed by Cardiopulmonary Exercise Testing performed before and after venous stenting of an ≥50% iliofemoral venous obstruction by MR or CT venography and confirmed by intra-procedural IVUS in a prospective patient cohort presenting with heart failure with preserved ejection fraction with a H2FpEF score of ≥4 AND a CEAP Category ≥3. Secondary Objectives: Identify patient demographic, baseline laboratory, imaging, procedural and Cardiopulmonary Exercise Testing variables and the FDA-approved Minnesota Living with Heart Failure Questionnaire as a Medical Device Development Tool (MDDT) in patients with and without functional improvement as assessed by Cardiopulmonary Exercise Testing VO2max after successful venous stenting of iliofemoral/iliocaval venous obstructions.
Study Type
OBSERVATIONAL
Enrollment
3
Prairie Heart Institute at St. Johns Hospital
Springfield, Illinois, United States
Evaluate potential change in metrics of functional capacity assessed by Cardiopulmonary Exercise Testing performed before and after venous stenting
The primary focus of the study is to estimate the change in functional capacity in patients of heart failure with preserved ejection fraction (HFpEF) of varying severities and chronic peripheral venous disease associated with pelvic venous obstruction after resolution via IVUS-guided venous stenting. Key estimate will be the change in functional capacity (i.e., VO2max or 6MWD) as assessed by the percentage change in pre- and post-venous stenting. No formal hypothesis tests are pre-specified.
Time frame: 180 days
Identify patient functional change utilizing the FDA-approved Minnesota Living with Heart Failure Questionnaire as a Medical Device Development Tool (MDDT) post treatment versus pre treatment
The secondary outcome measure of the study is to estimate the change in functional capacity in patients of heart failure with preserved ejection fraction (HFpEF) of varying severities and chronic peripheral venous disease associated with pelvic venous obstruction after resolution via IVUS-guided venous stenting. Key estimate will be the change in functional capacity as assessed by the percentage change in pre- and post-venous stenting utilizing the Minnesota Living with Heart Failure Questionnaire (MLHFQ). No formal hypothesis tests are pre-specified.
Time frame: 180 days
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